Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer
The purpose of this study is to evaluate progression free survival primarily. The secondary objectives are to evaluate the antitumor activity, as assessed by objective tumor response, duration of clinical benefit, overall survival, and the safety profile of TAS-109
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer|
- Percentage of Progression Free Survival [ Time Frame: From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months. ] [ Designated as safety issue: No ]The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.
- Antitumor Activity [ Time Frame: From the date of initial treatment until the date of the first objective documentation of PD or death from any cause. ] [ Designated as safety issue: No ]Per RECIST Criteria and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response rate was defined as percentage of patients of CR plus PR in ITT population.
- Overall Survival [ Time Frame: From the initial treatment until 12 months after enrollment of the last patient. ] [ Designated as safety issue: No ]Overall survival is defined as the period from the date of first dose of TAS-109 to death date.
|Study Start Date:||January 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
14-day continuous central intravenous infusion at a dose of 2.0 mg/m2/day followed by a 7-day rest period.
Number of cycles: until unacceptable toxicity or disease progression requires discontinuation.
|United States, New York|
|NYU Cancer Institute|
|East 34th Street, New York, New York, United States, NY 10016|
|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center|
|Holcombe Boulevard, Houston, Texas, United States, TX 77030|
|The Center for Cancer and Blood Disorders|
|West Magnolia Avenue, Fort Worth, Texas, United States, TX 76104|
|Principal Investigator:||Henry Xiong, M.D., Ph.D.||The Center for Cancer and Blood Disorders|